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Auricular Acupuncture for Treatment of Preoperative Anxiety (AcuAnx)

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ClinicalTrials.gov Identifier: NCT02656966
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:

In this prospective nonrandomized study the investigators are going to investigate whether auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative anxiety.

Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI) questionnaire) and will form the control group. The preoperative anxiety using STAI, as well as the duration and quality of sleep on the night before surgery, the incidence of side effects, blood pressure and heart rate will be the outcome measures in this study.


Condition or disease Intervention/treatment Phase
Anxiety Device: Auricular acupuncture Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Auricular Acupuncture vs. Standard Therapy for Treatment of Preoperative Anxiety in Patients Scheduled for Ambulatory Gynaecological Surgery - a Pilot Non-randomized Controlled Trial
Study Start Date : December 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Anxiety

Arm Intervention/treatment
Active Comparator: Auricular acupuncture + standard therapy
Patients, who will wish acupuncture, will receive this intervention, in addition to standard therapy
Device: Auricular acupuncture
Five ear acupuncture points: MA-IC, MA-TF1, MA-SC, MA-AT1 and MA-TG will be needled bilaterally in patients, who will wish to receive AA. Indwelling fixed "New Pyonex" needles (length: 1.5 mm, diameter: 0.22 mm; Seirin Corp., Shizuoka City, Japan) will be used for AA.

No Intervention: Standard therapy alone
Patients who do not wish acupuncture will be asked if they will fill in the study questionnaire



Primary Outcome Measures :
  1. Situational anxiety_1 [ Time Frame: Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture ]
    State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).

  2. Situational anxiety_2 [ Time Frame: Situational anxiety_2 will be measured and in the evening of the day before surgery ]
    State (situational) anxiety will be measured using State-Trait-Anxiety Inventory

  3. Situational anxiety_3 [ Time Frame: Situational anxiety_3 will be measured on the day of surgery immediately before the operation ]
    State (situational) anxiety will be measured using State-Trait-Anxiety Inventory


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: On the day of surgery before the surgery ]
  2. Blood pressure [ Time Frame: On the day of surgery before the surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia
  2. Surgery time does not exceed 60 minutes
  3. Patients without previous opioid and psychotropic medication
  4. Patients aged between 19 and 55 years, able to fill in the STAI questionnaire
  5. Patients who have given written informed consent

Exclusion Criteria:

  1. Current psychiatric disease
  2. Local skin infection at the sites of acupuncture
  3. Aged < 19 or > 55 years
  4. Failure to follow the standardized schema of general anaesthesia
  5. Surgery time more than 60 minutes
  6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
  7. Patients who consumed opioid medication at least 6 months before surgery
  8. Patients who are unable to understand the consent form or to fill in the STAI questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656966


Locations
Germany
University Medicine of Greifswald
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02656966     History of Changes
Other Study ID Numbers: BB 158/15
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders